PREPARING AN EFFECTIVE USER REQUIREMENTS SPECIFICATION

TO STREAMLINE WITH QUALIFICATION TASK

Jittaporn Wattanaseree, ISPE Thailand Affiliate

Get it Right on User Requirements Specification (URS)
13 June 2019, 9:00-10:30
BITEC, Bangkok, Thailand
 Functional
DQ, IQ, OQ Requirement GMP
Documentation Specification

User Basis of
Requirements Design
Functional
Requirement URS
Basic
Requirements
FDS TOR

Technical
Specification Design Purchasing
Documents Documents

Connecting Pharmaceutical Knowledge ispe.org

Contents
 INTRODUCTION
 MEANING AND IMPORTANCE OF URS
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING AN EFFECTIVE
URS

 URS PREPARATION PROCESS

 STRUCTURE OF A URS DOCUMENTATION
 HOW TO CREATE A BULLET PROOF REQUIREMENTS

 KEY CONSIDERATIONS FOR WORKING WITH VENDORS/SUPPLIERS

Connecting Pharmaceutical Knowledge ispe.org

Contents
 INTRODUCTION
 MEANING AND IMPORTANCE OF URS
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING AN EFFECTIVE
URS

 URS PREPARATION PROCESS

 STRUCTURE OF A URS DOCUMENTATION
 HOW TO CREATE A BULLET PROOF REQUIREMENTS

 KEY CONSIDERATIONS FOR WORKING WITH VENDORS/SUPPLIERS

Connecting Pharmaceutical Knowledge ispe.org

 CHALLENGES

Building Complex Process Technology Site Development

Building Site Development
Infrastructure &
Infrastructure &
Architectural /Civil
&& safety
safety system
system Architectural /Civil

Black
Black && Clean
Clean Utility
Utility
Systems
Systems M&E
M&E
HVAC,
HVAC, Clean
Clean Room
Room
Control
Control Systems
Systems
Process
Process Equipment
Equipment
Integrated Logistics
Maintenance &
Maintenance
System Warehousing
System

Scope vs Timeline Quality

Quality vsvs Cost
Cost
Qualification & Validation

Connecting Pharmaceutical Knowledge ispe.org

Milestone of building new facility : Project phases

Project Phasing
Conceptual phase Design phase Execution phase Validation phase

Cost Estimate ±20 % Cost Estimate ±10 %

Feasibility
Study

Conceptual Basic+ Ext Detailed

Design Basic Design Design

Procurement

Client Client Final Construction

Decision Investment
GO/NO GO Decision
GO/NO GO Qualification

Handover Validation
Support

Effective Start up
Annex
Connecting Pharmaceutical Knowledge ispe.org
 Key of success
 Right approach : Effective URS!
 Right decision on Contractor/suppliers selection
 No negotiation on quality of work
 Technical support from network, consultants and suppliers
 Apply GMP principle/concept to construction project since beginning
e.g. supplier audit, qualification proof record, personnel training and
QA on construction
 Team character: Target oriented, Flexibility and prompt action and
Friendship atmosphere

Connecting Pharmaceutical Knowledge ispe.org 7

 Good Manufacturing Practice - GMP

“มาตรฐานวิธีการที่ดีในการผลิตยา เป็น
แนวทางปฏิบัติในการผลิตยา ซึ่งเป็นส่วน
หนึ่งของระบบการประกันคุณภาพยา เพื่อให้มี
ความเชื่อมั่นว่า ยาที่ผลิตมีคุณภาพ
ประสิทธิภาพ และความ ปลอดภัย ตรงตามคุณภาพ
มาตรฐานที่กำหนดและสม่ำเสมอในทุกๆรุ่น
ประกาศกระทรวงสาธารณสุข เรื่อง “การกำหนดราย
ละเอียดเกี่ยวกับหลักเกณฑ์และวิธีการในการผลิต
ที่มีการผลิต”
ยาแผนปัจจุบันตามกฎหมายว่าด้วยยา
World Healthพ.ศ. 2559”
มาตรฐานวิธีการที่ดีในการ
Organization
ผลิตยา PIC/S GMP
Connecting Pharmaceutical Knowledge ispe.org 8
 GMP Goals
GMP Funct Focus on GMP Goals

Qualification, validation, quality

control, monitoring & stability study Product Quality

Patient Protection (GMP)

Quality
(Combined Guides)
Conduct bioequivalence Product Efficacy

Safety (Combined) Control contamination, impurity, Product Safety

degradation prod

Security Protect product from errors e.g. Product Security

(product secured from all
(Single Guide) mix-up, mislabeling, etc. errors)

Connecting Pharmaceutical Knowledge ispe.org

“GMP is that part of quality assurance aimed at ensuring
that products are consistently manufactured to a quality
appropriate to their intended use”

Connecting Pharmaceutical Knowledge ispe.org 10

 Qualification and Validation Phases

URS: User Requirement Specification ข้อกำหนดความ

ต้องการของผู้ใช้
DQ: Design Qualification การตรวจรับรองการออกแบบ
IQ: Installation Qualification การตรวจรับรองการติด
ตั้ง
OQ: Operational Qualification การตรวจรับรองการทำงาน
PQ: Performance Qualification การตรวจรับรองสมรรถนะ
BPR: Batch Production
Connecting Pharmaceutical
บันทึกการผลิต
RecordKnowledge ispe.org 11
 ประกาศ สธ 2559 เรื่องหลักเกณฑ์และวิธีการ
ผลิตยา ภาคผนวก 14, หน้า 14-15
Connecting Pharmaceutical Knowledge ispe.org 12
 PROJECT INITIATION

 RECRUIT PROJECT MANAGER AND TEAM

 REVIEW RELATED INFORMATION/STUDIES

 ESTABLISH PROJECT OBJECTIVE ,SCOPE, TIMELINE

 ESTABLISH PROJECT REQUIREMENT AND QUALITY STANDARD

 ESTABLISH PROJECT APPROACH ( break down or turnkey)

 PREPARE PROJECT BUDGET & SCHEDULE including PROCUREMENT PLAN

 CREATE PROJECT ORGANIZATION , ROLE & RESPONSIBILITY

 CREATE PROJECT ASSESSMENT & CONTROL PROCEDURE

 ESTABLISH WAY OF COMMUNICATION ,EXTERNAL AND INTERNAL

 IDENTIFY NEED FOR TRAINING OR/AND CONSULTANCY

 REVIEW ALL INITIAL PLANS including payment plan

Connecting Pharmaceutical Knowledge ispe.org

PROJECT PLANING , DESIGN, AND EXECUTION
 DEFINE PROCESS TECHNOLOGY

 DEFINE REGULATORY REQUIREMENT ( at which standard )

 DEFINE QC LAB REQUIREMENT

 PREPARE BUILDING URS (including technical specification of supply services)

 PREPARE CLEAR PROCESS FLOWS

 PREPARE LIST OF PROCESS EQUIPMENT AND IT’s URS

 PREPARE CONCEPTUAL LAYOUT ( including utility point of use)

 DEFINE NUMBER OF STAFF/ORGANIZATION CHART

 DEFINE OPERATING PHYLOSOPHY/ OPERTING BUDGET EXPECTATION
 BLD MAINTENAINCE PHYLOSOPHY
 REVIEW POTENTIAL OF EXPANSION AND FLEXIBILITY
 REVIEW LOCAL REGULATORY ISSUES e.g. ENVIRONMENT, BIOSAFETY etc.
 QA SYSTEM DEFINITION
 PREPARE PROJECT ACTIVITIES (GANTT CHART) END-TO -END

Connecting Pharmaceutical Knowledge ispe.org

PROJECT WORK FLOW: MACHINERY/EQUIPMENT

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ASTM E2500-07

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Connecting Pharmaceutical Knowledge ispe.org 18
 Functional
DQ, IQ, OQ Requirement GMP
Documentation Specification

User Basis of
Requirements Design
Functional
Requirement URS
Basic
Requirements
FDS TOR

Technical
Specification Design Purchasing
Documents Documents

Connecting Pharmaceutical Knowledge ispe.org

 User Requirements Specification : URS
Ref: PIC/S PE-009 Annex 15 ( Qualification and Validation )

“The set of owner, user, and engineering requirements

necessary and sufficient to create a feasible design meeting the
intended purpose of the system.”
ข้อกำหนดความต้องการของเจ้าของ ผู้ใช้ และด้านวิศวกรรม ซึ่งมีรายละเอียดที่จำเป็นและ
เพียงพอ ที่จะออกแบบชิ้นงานได้ตรงตามวัตถุประสงค์การใช้งานของระบบที่ต้องการนั้น

สธ 2559 เรื่องหลักเกณฑ์และวิธีการผลิตยา ภาคผนวก 14

Connecting Pharmaceutical Knowledge ispe.org 20

 User Requirements Specification
URS specifies the requirements the user expects from systems to be constructed in a new project

An important and difficult step of designing systems are determining what the owner actually
wants it to do. This is because often the owner is not able to communicate the entirety of their
needs and wants, and the information they provide may also be incomplete, inaccurate and self-
conflicting.

The responsibility of completely understanding what the owner wants then falls on the providers
of the product.

Once the required information is completely gathered, it is documented in a URS, which is meant
to spell out exactly what the function must do and becomes part of the contractual agreement.

An owner cannot demand features not in the URS without renegotiating and a designer cannot
claim the system is ready if it does not meet an item of the URS.

Connecting Pharmaceutical Knowledge ispe.org 21

The User is responsible for defining “WHAT” the equipment is suppose to do. (It may be written by a third party but should be
approved by the User.) * The Users are responsible for Supplier education

Connecting Pharmaceutical Knowledge ispe.org 22

 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING AN EFFECTIVE URS

ประกาศ สธ 2559 เรื่องหลักเกณฑ์และวิธีการผลิตยา ภาคผนวก 14

(การตรวจรับรองและการตรวจสอบความถูกต้อง)

ประกาศ สธ 2559 เรื่องหลักเกณฑ์และวิธีการผลิตยา

ภาคผนวก 10 (ระบบที่ใช้คอมพิวเตอร์)

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Connecting Pharmaceutical Knowledge ispe.org 24
3. QUALIFICATION STAGES FOR EQUIPMENT, FACILITIES, UTILITIES AND SYSTEMS.

3.1 Qualification activities should consider all stages from initial development of the user
requirements specification through to the end of use of the equipment, facility, utility or system.
The main stages and some suggested criteria (although this depends on individual project
circumstances and may be different) which could be included in each stage are indicated below:

User requirements specification (URS)

3.2 The specification for equipment, facilities, utilities or systems should be defined in a URS
and/or a functional specification. The essential elements of quality need to be built in at this stage
and any GMP risks mitigated to an acceptable level. The URS should be a point of reference
throughout the validation life cycle

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Connecting Pharmaceutical Knowledge ispe.org 26
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING AN EFFECTIVE URS

PIC/S GMP GUIDE PE 009- 14, Annex 11 (computerized system), p 88, PROJECT PHASE

PIC/S PI 011-3, 2007, PIC/S Guidance: Good practices for computerized systems in regulated GxP environment

Connecting Pharmaceutical Knowledge ispe.org 27

 IC: Installation Commissioning
Relationship & Life Cycle OC: Operation Commissioning
PC: Performance Commissioning
IQ: Installation Qualification
OQ: Operation Qualification
PQ: Performance Qualification

Owner (w vendor) PQ

Vendor OQ =
OC+OQ

Vendor IQ = IC+IQ

Build
Manufacture/Fabricate

Connecting Pharmaceutical Knowledge ispe.org 28

V-Model Cross Verification Matrix*

Connecting Pharmaceutical Knowledge ispe.org

 User/Consultant (if applicable) Supplier
Assessment Supplier Impact Assessment
Project Impact Assessment • Initiated by User
• Quality Practices
• Vendor Audit / Evaluation
Master Validation Plan
Engineering Feasibility Study /
User Requirement Specification PO
Proof of Concept
• Perform System Impact Assessment RFQ
• Initiate Risk Assessment Develop Proposal
• Provide Input to Risk Assessment
RFQ
Project/Unit C&Q Plan • Develop Supplier Test Matrix
al (Supplier’s Test Expectations)
p os
P ro
Proposal Analysis PO Develop Functional Specification
ec Traceable to the URS
Sp

Review Functional Specification Create Initial Traceability Matrix

Living Documents - Inputs for

Ap

JETT Equipment
p ro
va Develop Risk Assessment Docs
l
Detail with User
Acquisition Model Review/Approval Detailed Design Detail Doc Develop Detailed Design Docs

Traceability
Version 006 • Finalize Risk Assessment Ap Traceable to the Functional Specification
p ro
v al

Revision
Review Supplier Commiss. Docs Develop Test Documents
Test Docs
Develop Additional Commissioning Documents FAT - SAT - Commissioning Tests
(if required) Ap
pro
val

Execute Commissioning Execute Test Documents

Results
Update Traceability Matrix User Participation is Optional

Develop SOPs Manuals

Provide User, Operational, &
Maintenance Manuals/Training

Develop IQ/OQ Protocols

Update Traceability Matrix

Execute IQ/OQ Protocols

Write Final Summary Reports

Protocol - Validation - Traceability Matrix - C&Q

Connecting Pharmaceutical Knowledge ispe.org

JETT Equipment Acquisition Model
Version 006

Connecting Pharmaceutical Knowledge ispe.org

JETT Equipment Acquisition Model (cont.)
Version 006

Connecting Pharmaceutical Knowledge ispe.org

 What is Requirements Traceability Matrix?

Requirements Traceability Matrix (RTM)

is a matrix of the requirements for facility/utility/equipment
 developed by supplier
 using available URS given by user

All specifications related to user requirements (intended uses),

functional and detail design specifications are now completed
in the matrix format as follows ………
Connecting Pharmaceutical Knowledge ispe.org 33
Connecting Pharmaceutical Knowledge ispe.org 34
Connecting Pharmaceutical Knowledge ispe.org 35
Qualification &Validation Documents Hierarchy

Connecting Pharmaceutical Knowledge ispe.org 36

 Plant “Facility URS is driven by Process.”
Design
Concept

Connecting Pharmaceutical Knowledge ispe.org

Contents
 MEANING AND IMPORTANCE OF URS
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING
AN EFFECTIVE URS
 URS PREPARATION PROCESS
 STRUCTURE OF A URS DOCUMENTATION
 HOW TO CREATE A BULLET PROOF REQUIREMENTS

 KEY CONSIDERATIONS FOR WORKING WITH VENDORS/SUPPLIERS

Connecting Pharmaceutical Knowledge ispe.org

 URS PREPARATION PROCESS
1. Set up a team (may include SME) and scope of ownership. Educate team
to have fully understand background knowledge necessary to fulfill their
role of involvement.
2. Draft up requirements with clear concise manner and one requirement
at a time.
NB: Requirements should be Specific, Measurable, Achievable, Realistic, Testable and
Traceable through the life cycle
3. Prioritize your requirements ( Mandatory, Beneficial, Nice to have )
5. Configured product, the processes to be automated should be aligned
well with the functionality of the product to be used.

Connecting Pharmaceutical Knowledge ispe.org 39

Connecting Pharmaceutical Knowledge ispe.org 40
 URS PREPARATION
 URS PREPARATION PROCESSPROCESS
(cont.) (cont.)

6. Supplier audit / assessment, as part of quality planning

process and QMS set forth.
7. Enable clear communication (internal/external) and
management of critical requirements throughout the life cycle.
8. Design review and perform traceability
9. Update initial requirement according to available information.
10. Review, approve and control changes to of specifications
which may affect to the approved requirements

Connecting Pharmaceutical Knowledge ispe.org 41

 PLE
A M
E X

Connecting Pharmaceutical Knowledge ispe.org 42

 PLE
A M
E X

Equipment suppliers “respond” to the URS with their FDS

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 PLE
A M
E X

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Connecting Pharmaceutical Knowledge ispe.org 45
 E Cleanroom URS Given by Owner
L
A MP (GMP Impact Requirements at Minimum)
E X
URS FDS DDS
Cleanroom air Materials – floor, wall, ceiling,
cleanliness grade C piping (PW, CD)
(WHO-GMP, ISO 14644
series) – continued

Smooth surface, coved corner

Provision for maintenance access

and space

By owner user
46
 E Cleanroom URS Given by Owner
L
A MP (GMP Impact Requirements at Minimum)
E X
URS FDS DDS
Cleanroom air
cleanliness grade C
(WHO-GMP, ISO 14644
series)
HEPA 99.97% (H13) (Camfil or
AAF)
Air change > 20 4 rooms @ 6x10x3 m3

By owner user By owner designer

47
 E Cleanroom URS Completed by Supplier
L
A MP GXP Requirements Traceability Matrix (RTM)
E X
URS FDS DDS
Cleanroom air Facilitate cleanability Materials – floor, wall, ceiling,
cleanliness grade C (GMP aspect) piping (PW, CD)
(WHO-GMP, ISO 14644
series) – continued Mat’ls: epoxy, sandwich panel,
SS316L, SS304
Smooth surface, coved corner

Facilitate Provision for maintenance access

maintainability (GMP and space
aspect)
By owner user Materials: Proposed by contractor
48
 E Cleanroom URS Completed by Supplier
L
A MP GXP Requirements Traceability Matrix (RTM)
E X
URS FDS DDS
Cleanroom air Remove coarse dust Pre-filters 30-35% (G4)
cleanliness grade C
(WHO-GMP, ISO 14644
series) Remove fine dust Med. filters 90% (F8)
Generate clean air < HEPA 99.97% (H13) (Camfil or
As-built count<30% 30% of grade C AAF)
Air change > 20 Supply air at calculated 4 rooms @ 6x10x3 m3
CFM
Design AC 40 Blower & motor capac.
By owner user By owner designer All reviewed/approved by
consultant/SME
All reviewed/proposed by contractor
49
 User/Consultant (if applicable) Supplier
Assessment Supplier Impact Assessment
Project Impact Assessment • Initiated by User
• Quality Practices
• Vendor Audit / Evaluation
Master Validation Plan
Engineering Feasibility Study /
User Requirement Specification PO
Proof of Concept
• Perform System Impact Assessment RFQ
• Initiate Risk Assessment Develop Proposal
• Provide Input to Risk Assessment
RFQ
Project/Unit C&Q Plan • Develop Supplier Test Matrix
al (Supplier’s Test Expectations)
p os
P ro
Proposal Analysis PO Develop Functional Specification
ec Traceable to the URS
Sp

Review Functional Specification Create Initial Traceability Matrix

Living Documents - Inputs for

Ap

JETT Equipment
p ro
va Develop Risk Assessment Docs
l
Detail with User
Acquisition Model Review/Approval Detailed Design Detail Doc Develop Detailed Design Docs

Traceability
Version 006 • Finalize Risk Assessment Ap Traceable to the Functional Specification
p ro
v al

Revision
Review Supplier Commiss. Docs Develop Test Documents
Test Docs
Develop Additional Commissioning Documents FAT - SAT - Commissioning Tests
(if required) Ap
pro
val

Execute Commissioning Execute Test Documents

Results
Update Traceability Matrix User Participation is Optional

Develop SOPs Manuals

Provide User, Operational, &
Maintenance Manuals/Training

Develop IQ/OQ Protocols

Update Traceability Matrix

Execute IQ/OQ Protocols

Write Final Summary Reports

Protocol - Validation - Traceability Matrix - C&Q

Connecting Pharmaceutical Knowledge ispe.org

 GAMP Scope: “Automated Systems”
Consist of:
 Hardware - Controlled Functions
 Software - Network Components
 Associated Documentation
Applies to:
 Automated Manufacturing Equipment
 Control Systems
 Automated Laboratory Systems
 Manufacturing Execution Systems
 Computers Running Manufacturing or Laboratory Databases
Connecting Pharmaceutical Knowledge ispe.org
Connecting Pharmaceutical Knowledge ispe.org 52
Contents
 MEANING AND IMPORTANCE OF URS
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING
AN EFFECTIVE URS
 URS PREPARATION PROCESS
 STRUCTURE OF A URS DOCUMENTATION
 HOW TO CREATE A BULLET PROOF REQUIREMENTS

 KEY CONSIDERATIONS FOR WORKING WITH VENDORS/SUPPLIERS

Connecting Pharmaceutical Knowledge ispe.org

Connecting Pharmaceutical Knowledge ispe.org 54
Connecting Pharmaceutical Knowledge ispe.org 55
Equipment suppliers “respond” to the URS with their FDS

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Connecting Pharmaceutical Knowledge ispe.org 57
 ISPE GAMP Good Practice Guides
Purpose is to …..
“ Help suppliers of automated systems to the pharmaceutical industry ensure that systems are
developed following good practice and to provide proper documentary evidence that their systems
meet the agreed specifications. ”

Connecting Pharmaceutical Knowledge ispe.org 58

 t io n What is GAMP & JETT?
rm a Good Automated Manufacturing Practice
In f o
o u r
o r Y A set of ISPE’s Industry Guidelines written by a
F technical subcommittee of ISPE for manufacturers
and users of automated systems on validation of
the systems to ensure that systems are developed
following good practice and to provide proper
documentary evidence that their systems meet the
agreed specifications, fit for use and compliant with
regulation.

Joint Equipment Transition Team

• Special Interest Group of GAMP
• Selected GAMP as “common ground.”
• Meet Monthly for review and development

JETT Mission: Improve communications between Users and Suppliers to more effectively
meet the “validation” requirements of the pharmaceutical industry.
JETT’s URS Templates

Connecting www.jettconsortium.com
PharmaceuticalKnowledge ispe.org 59
ISPE GAMP Guide Part 1: User Responsibilities

Validation (Master) Plan & System Specific Validation Plan(s)

Appendix 6
Supplier Audit
o n
Appendix 7 t i
a
o rm
User Requirements Specification n f
u rI
Appendix 5 o
rY
Supplier Education Fo

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 PLE
A M
E X

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Connecting Pharmaceutical Knowledge ispe.org 62
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Connecting Pharmaceutical Knowledge ispe.org 64
 L E
A MP
E X

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 PLE
AM
EX
TABLE OF CONTENTS
1.0 INTRODUCTION.............................................................................................. 5
2.0 OVERVIEW ....................................................................................................... 5
3.0 OPERATIONAL REQUIREMENTS .............................................................. 6
3.1 CAPACITY ........................................................................................................ 6
3.2 PROCESS REQUIREMENTS ............................................................................... 6
3.3 PROCESS CONTROL ......................................................................................... 6
3.4 FUNCTIONS ...................................................................................................... 7
3.5 DATA AND SECURITY ....................................................................................... 9
3.6 ENVIRONMENT .............................................................................................. 11
4.0 CONSTRAINTS ............................................................................................... 14
4.1 MILESTONES AND TIMELINES ....................................................................... 14
4.2 EQUIPMENT CONSTRAINTS ........................................................................... 15
4.3 COMPATIBILITY AND SUPPORT ..................................................................... 15
4.4 AVAILABILITY ............................................................................................... 17
4.5 PROCEDURAL CONSTRAINTS ........................................................................ 17
4.6 MAINTENANCE .............................................................................................. 19
5.0 LIFE-CYCLE ................................................................................................... 19
5.1 DEVELOPMENT .............................................................................................. 19
5.2 TESTING ......................................................................................................... 19
5.3 DELIVERY ...................................................................................................... 20
5.4 SUPPORT ........................................................................................................ 21
6.0 GLOSSARY...................................................................................................... 22
7.0 REFERENCES ................................................................................................. 23
8.0 APPROVAL ..................................................................................................... 24

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 P L E
XA M
E

PS System
URS

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EXAMPLE Facility URD

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 URS TEMPLATE

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 EXAMPLE 3

EXAMPLE 2

EXAMPLE 1

Connecting Pharmaceutical Knowledge ispe.org 70

Contents
 MEANING AND IMPORTANCE OF URS
 REGULATORY REQUIREMENTS AND EXPECTATION FOR WRITING
AN EFFECTIVE URS
 URS PREPARATION PROCESS
 STRUCTURE OF A URS DOCUMENTATION
 HOW TO CREATE A BULLET PROOF REQUIREMENTS

 KEY CONSIDERATIONS FOR WORKING WITH VENDORS/SUPPLIERS

Connecting Pharmaceutical Knowledge ispe.org

Part 1 of the GAMP Guide outlines very valuable information for the User.

* It describes the Validation Master Plan which is the “big picture” validation activities and is
typically approved by management and QA. System Specific Validation Plan is a Validation
Plan developed for the Suppliers that defines their responsibilities for specification and testing
so that what they do can be utilized as part of the overall validation plan. You will not find the
term (System Specific) used widely in GAMP. Its alluded to in the explanations of how
documents and specifications should flow and therefore we’ve started using that term more
commonly.

* According to GAMP, each Supplier should be formally audited to ensure the quality of the
services or equipment they supply. The audit should be done prior to seeking
equipment/services from the Supplier.

* The User is responsible for defining “WHAT” the equipment is suppose to do. It may be
written by a third party but should be approved by the User.
* The Users are responsible for Supplier education.

Connecting Pharmaceutical Knowledge ispe.org 72

 in t
l h
ic a
c t
P ra

Connecting Pharmaceutical Knowledge ispe.org

 URS, FDS and Contract Specification (CS) are linked with each other
(example for standard equipment)

n t
h i
a l
t ic
a c
P r

NB: When more than one (potential) supplier is involved: more than 1 DQ may be required

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Connecting Pharmaceutical Knowledge ispe.org 75
Connecting Pharmaceutical Knowledge ispe.org 76
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Connecting Pharmaceutical Knowledge ispe.org 78
OCTAGONAL BLENDER

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 Summary
1. The user requirements specification (URS) is the key document that is
required for;

 business (investment protection)

 regulatory reasons (defining intended purpose).

The URS should be complete, realistic, definitive and testable.

Spend sufficient time defining, writing and reviewing “a testable URS”

2. Contract Specification (CS): FDS/FS approved by User + Supplier

Selecting the right supplier - the Users are responsible for “Supplier education”

Connecting Pharmaceutical Knowledge ispe.org 80

 Summary
3. Equipment that reliable and suiting the demand of production process
and final product is;

URS + FDS= Basic of safe products and reliable processes

Connecting Pharmaceutical Knowledge ispe.org 81

 Project’s vow
To achieve the goal of certification

of level of National control authority and International standard,

Pharmaceutical manufacturers, contractors and suppliers

have to

overcome burdens and break through all barriers.

“Owner and contractor have to believe in the same standard of quality

honest and respect to each other expertise

as well as

believe in team work “together we can do ”

Connecting Pharmaceutical Knowledge ispe.org

Connecting Pharmaceutical Knowledge ispe.org
It’s coffee time!
Let’s practice and enjoy….

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 THANK YOU

FOR YOUR ATTENTION

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